Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-01 @ 8:43 PM
Study NCT ID:
NCT03720132
Status:
TERMINATED
Last Update Posted:
2018-10-29
First Post:
2016-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Emerging evidence made the trial unnecessary.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-25', 'studyFirstSubmitDate': '2016-11-29', 'studyFirstSubmitQcDate': '2018-10-23', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vancomycin trough levels via port catheter and peripheral vein', 'timeFrame': 'At steady state i.e. approximately 36 hours after initation of the treatment or a change in dose', 'description': 'Vancomycin trough levels will be determined, both on peripheral blood and blood taken via the port catheter and will be compared.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vancomycin', 'Therapeutic drug monitoring', 'Catheter related blood stream infections'], 'conditions': ['Catheter Related Blood Stream Infections']}, 'referencesModule': {'references': [{'pmid': '19569969', 'type': 'BACKGROUND', 'citation': 'Rybak MJ, Lomaestro BM, Rotschafer JC, Moellering RC, Craig WA, Billeter M, Dalovisio JR, Levine DP. Vancomycin therapeutic guidelines: a summary of consensus recommendations from the infectious diseases Society of America, the American Society of Health-System Pharmacists, and the Society of Infectious Diseases Pharmacists. Clin Infect Dis. 2009 Aug 1;49(3):325-7. doi: 10.1086/600877.'}, {'pmid': '21039771', 'type': 'BACKGROUND', 'citation': 'Wright DF, Al-Sallami HS, Jackson PM, Reith DM. Falsely elevated vancomycin plasma concentrations sampled from central venous implantable catheters (portacaths). Br J Clin Pharmacol. 2010 Nov;70(5):769-72. doi: 10.1111/j.1365-2125.2010.03749.x. No abstract available.'}, {'pmid': '19489710', 'type': 'BACKGROUND', 'citation': "Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376."}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to verify whether extensive flushing of the port catheter in patients with catheter related blood stream infection will lead to correct vancomycin trough levels, taken via the port catheter and compared with simultaneously taken peripheral samples.', 'detailedDescription': 'In this study, extensive flushing of the port catheter prior to blood sampling to determine vancomycin trough levels, will be compared with normal flushing. To ascertain correctness of the trough levels taken via the central catheter, sampling will occur through a peripheral catheter simultaneously.\n\nFlushing will be done with sodium chloride 0.9 % solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients with a port catheter\n* Treated with systemic vancomycin and/or vancomycin "lock"\n\nExclusion Criteria:\n\n* Age \\> 18 years\n* Active downgrading of care'}, 'identificationModule': {'nctId': 'NCT03720132', 'briefTitle': 'Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter', 'orgStudyIdInfo': {'id': 'S20140519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with port catheter: flushing', 'description': 'In patients with a catheter-related blood stream infection (CRBSI) and a port catheter, being treated with vancomycin intravenously, we will flush the catheter with 30 ml of sodium chloride 0.9 % prior to blood sampling to determine vancomycin concentrations, in order to decrease residuel vancomycin in the port.', 'interventionNames': ['Procedure: Extensive flushing of the port catheter']}], 'interventions': [{'name': 'Extensive flushing of the port catheter', 'type': 'PROCEDURE', 'description': 'The port catheter will be flushed extensively with sodium chloride 0.9% before blood sampling. Blood sampling will occur through the central catheter and peripherally simultaneously.', 'armGroupLabels': ['Patients with port catheter: flushing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitaire Ziekenhuizen Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Isabel Spriet, PharmD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PharmD, PhD', 'investigatorFullName': 'Isabelle Spriet', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}